May Griffith, PhD, University of Montreal & Hopital Maisonneuve-Rosemont, Montreal, Canada, provides an overview of designing biomaterials for clinical trials and problems associated with the process. Prof. Griffith emphasizes the need for long-term planning and careful consideration of multiple variables including scalability and safety for successful authorization by regulatory authorities. This interview took place at the 6th World Congress of the Tissue Engineering and Regenerative Medicine International Society (TERMIS 2021).